MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PACK,COLD,INSTANT,STANDARD,6"X9"

Catalog Number	MDS137000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burn(s) (1757); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Blister (4537)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, after applying the ice pack for "groin pain" for "a little while" to the "left side" of the groin on (b)(6) 2025 he felt a "burning sensation", and the skin "looked like a huge blister (bubbled up skin)".The customer reported that the following day the "top skin was gone", and there was "raw flesh with a hole".The customer reported he visited his physician and was prescribed "antibiotics and cream".The customer reported that the skin is now a "purple looking scar", and the doctor stated, "it was frost bite and that there will be permanent nerve damage in that area".No additional details are available related to the customer reported issue.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, after applying the ice pack for "groin pain" for "a little while" to the "left side" of the groin on (b)(6) 2025 he felt a "burning sensation", and the skin "looked like a huge blister (bubbled up skin)".The customer reported that the following day the "top skin was gone", and there was "raw flesh with a hole".

• Brand Name: MEDLINE
• Common Device Name: PACK,COLD,INSTANT,STANDARD,6"X9"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24094614
• Report Number: 1417592-2026-00051
• Device Sequence Number: 13336149
• Product Code: IMD
• UDI-Device Identifier: 00080196732336
• UDI-Public: 00080196732336
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDS137000
• Device Lot Number: 08019673233
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male